BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EC4+ CARTRIDGE

    MDR report key: 8522245 · Received April 17, 2019

    Report

    Report Number
    2245578-2019-00103
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    March 7, 2019
    Report Date
    May 28, 2019
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749000095
    PMA / PMN Number
    K912387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT #: (B)(4). THE INVESTIGATION WAS COMPLETED ON 05/24/2019. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AD (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN DETERMINED FOR EC4+ LOT K18295.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT #: (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2019, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EC4+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULTS ON A (B)(6) YEAR OLD FEMALE PATIENT WITH END STAGE RENAL DISEASE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD: I-STAT, DATE: (B)(6) 2019, TESTED: 07:47, RESULTS: 5.8 MG/DL, SAMPLE: A. I-STAT, (B)(6) 2019, 08:53, 7.5 MG/DL, B. COLLECTION TIME NOT PROVIDED. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315368 I-STAT EC4+ CARTRIDGE EC4+ CARTRIDGE JGS ABBOTT POINT OF CARE NA K18295 10054749000095

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR